Home / Recalls / Thermedx LLC / Z-2555-2014

Z-2555-2014 Class II Terminated

Recalled by Thermedx LLC — Solon, OH

Recall Details

Product Type: Devices
Report Date: September 3, 2014
Initiation Date: February 10, 2014
Termination Date: August 4, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21

Product Description

The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.

Reason for Recall

A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.

Distribution Pattern

Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.

Code Information

Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005